Extractor for removing a lead from a patient

ABSTRACT

An extractor for removing an implanted lead from a patient, the extractor comprising a proximal portion, a distal portion, a lumen dimensioned to receive the lead therein, a cutter at the distal portion for cutting tissue adjacent the implanted lead, and a first clamping member movable between a clamping position to clamp the lead and an unclamping position to unclamp the lead. The extractor and lead are relatively movable to remove the lead.

This application claims the benefit of U.S. Provisional Application No.61/869,729 filed Aug. 25, 2013, the entire contents of which areincorporated herein by reference.

BACKGROUND Technical Field

The invention relates to an extractor for removing an implanted leadfrom a patient, such as a cardiac pacing lead.

Background of Related Art

Recently, implantation of cardiac pacing devices has become a standardmedical intervention for correcting cardiac rhythm thereby reducingpatient's health complaints due to an abnormal cardiac condition.

The cardiac pacing device, such as a pacemaker, includes one or moreelectrical leads which supply a due electrical stimulus from thepacemaker or implantable cardioverter defibrillator to the heart muscle.These electrodes are implanted in the heart tissue, i.e., in a vein inthe heart such as the superior vena cava or subclavia vena which maytake place during open heart surgery. The distal portion of theelectrical leads may include anchors for affixing the electrode leadinside the heart muscle. The electrode wire is covered with a suitablelayer of insulator for electrical safety in operation. The leads canhave an externally threaded tip to screw into the tissue.

During use, the electrical lead may be damaged or may need to bereplaced due to maintenance considerations. This procedure is usuallycomplicated by the fact that during the time the lead has dwelled insidethe body, it has grown into a scar tissue as well as it may be coveredby tissue as the result of tissue ingrowth. Tissue ingrowth can occuralong various portions of the lead. It is appreciated that bothphenomena make it difficult to remove the electrode lead from the hearttissue. This is especially the case since the vein makes a curve fromthe pacemaker to the heart and the lead is often attached to the vein atthis curve, thereby making release difficult.

Through the years different attempts have been made to provide asuitable lead extractor device which is capable of removing an implantedelectrical lead without causing damage to the patient.

Originally, lead extractors were mechanical devices operable by acardiac surgeon to free the leads from the surrounding tissue forremoving them from the heart. The disadvantage of such devices is that amechanical force is initially applied in the region of a manifold of thelead extractor and has to be suitably transferred to a distant locationalong the lead for freeing it from the tissue. Usually the leadextraction is carried out using a subclavian approach or femoralapproach. In both approaches a sheath is placed over the lead and isthreaded over the lead to reach the distal portion, i.e., the tip, ofthe lead. However, it has been clinically found that such mechanicalapproach has a high risk of undesirable disruption of the tissue of thepatient when attempting to free the implanted electrode lead from theheart muscle. Also, the hardened tissue around the lead can in someinstances make placement of the sheath difficult.

A particular version of a lead extractor is disclosed in U.S. Pat. No.4,574,800, which is arranged to remove implanted leads from a patient bygrasping the lead substantially close to its implantation position.Accordingly, this extractor device includes an elongate tubular memberarranged to slide into and through a longitudinal lumen of the cardiacpacing lead. The distal portion of the elongate tubular member comprisesa protrusion member adapted to provide a wedging surface. The wedgingsurface is effected by a tapering proximal surface of the protrusionmember. The proximal tapering surface may take the form of a sphericalor a conical section. The elongate tubular member further includes aspherical gripping member arranged to engage with the lead. When theproximal end portion of the elongate member is pulled with a substantialforce, for example, by suitable actuation of the handle, the protrusionmember forms a flared distal end section of the elongate tubular member.The elongate tubular member has a length such that it projects beyondthe proximal end of the cardiac lead when the known extractor is fullyinserted into the lead. In use, the extractor assembly is inserted intoand through the cardiac pacing lead until the protrusion member abutsthe proximal end of the implanted electrode. Afterwards, the protrusionmember is activated to cause the distal portion of the tubular member towedge. The wedged portion comes into frictional engagement with theinside surface of the distal portion of the cardiac pacing lead.Finally, a pulling force is applied to the proximal portion of theelongate tubular member, which is transmitted to the distal portion ofthe elongate tubular member towards the flared portion. This pulls thecardiac pacing lead from its dwelling.

Although in the foregoing system's excessive force to the electrode wireand its insulator sheath may be avoided, the pulling forces, which aretransferred from the proximal end of the lead extractor, may causeundesirable local damage to the tissue. Additionally, since the leadextractor is provided inside the lumen of the lead, it has to meetstringent constraints regarding its permissible dimensions. This limitsthe possibilities of optimization of the lead extractor in terms ofmechanics.

Other prior art attempts to extract leads involve inserting a tube overthe lead and drilling down with the tube to separate surrounding tissuefrom the external surface of the lead to free the lead. Still otherprior art methods include utilizing lasers or electrosurgical energy,such as radiofrequency energy at the end of a catheter to sever thetissue.

The need exists for a simplified and less traumatic approach to removingleads, such as cardiac leads, from a patient.

SUMMARY

The present device provides an improved lead extractor which is capableof secure removal of the implanted leads, such as cardiac leads, causingminimum damage to the patient's tissue. The lead is clamped by theextractor and incremental relative movement of the lead and retractormoves the lead within the extractor lumen as tissue surrounding the leadis cut (dissected) by the extractor.

In one aspect, the present invention provides an extractor for removingan implanted lead from a patient, the extractor comprising a proximalportion, a distal portion, a lumen dimensioned to receive the leadtherein, and a cutter at the distal portion of the extractor for cuttingtissue adjacent the implanted lead. A first clamping member is spacedproximally of the cutter, the first clamping member movable between aclamping position to clamp the lead and an unclamping position tounclamp the lead, and the extractor and lead are relatively movable toremove the lead.

In some embodiments the extractor further includes a movement mechanismoperatively associated with the first clamping member, the movementmechanism movable between proximal and distal positions to alter anorientation of the first clamping member to move it between the clampingand unclamping positions.

In some embodiments, the first clamping member includes a firstpivotable ring member having an opening therethrough to receive the leadtherethrough, wherein the first pivotable ring member is tiltablerelative to a longitudinal axis of the lead to apply a clamping force onthe lead to clamp the lead when in a more tilted position. The extractorcan further include a second pivotable clamping member, and the secondclamping member can comprise a second ring member axially spaced fromthe first ring member and having an opening therethrough to receive thelead therethrough and tiltable relative to the longitudinal axis of thelead to apply a clamping force on the lead to clamp the lead when in amore tilted position. In some embodiments, the first and secondpivotable ring members are alternatively movable between the clamped andunclamped positions so that the first pivotable ring member clamps thelead while the second pivotable ring member is in an unclamped positionto allow relative movement of the lead therethrough and the secondpivotable ring member clamps the lead while the first pivotable ringmember is in an unclamped position to allow relative movement of thelead therethrough.

In some embodiments, the extractor further includes a housing and acarrier slidably mounted within the housing, the first clamping memberpositioned within the carrier, and axial movement of the carrier movesthe first clamping member axially. In some embodiments, movement of thecarrier in a proximal direction moves the lead further in the lumen ofthe extractor. In some embodiments, the extractor further includes asecond clamping member positioned distal of the carrier.

In some embodiments, the extractor includes a second clamping member,wherein the first clamping member has a first hinge and the secondclamping member has a second hinge, the first and second hinges radiallyspaced from a longitudinal axis of the extractor and lying on opposingsides of the longitudinal axis of the extractor.

The extractor can further include a cable operatively associated withthe first clamping member, wherein distal movement of the cable advancesthe first clamping member distally and proximal movement of the cableretracts the first clamping member proximally.

The extractor can include a second clamping member and a stop to limitdistal travel of the second clamping member, wherein the stop can beoverridden to release the first and second clamping members.

In some embodiments, the cutter is both axially movable and rotatableconcurrently with axial movement of the first clamping member. In someembodiments, the extractor further comprises an outer tube or housing,the cutter positioned at a distal portion of the outer tube and theouter tube having a helical slot for rotational movement of the outertube.

In some embodiments, the extractor includes a second clamping member,wherein movement of the extractor is effected by alternate movement ofthe first and second clamping members to incrementally move the lead andextractor relative to one another as the tissue is cut, e.g., severedand/or dissected, by the cutter.

In some embodiments, the movement mechanism is controlled by an externalpower source connected to the movement mechanism.

In some embodiments, a flexible sheath is provided which is rotatablewith respect to the extractor to unscrew a distal tip of the lead fromtissue.

In another aspect, the present invention provides an extractor forremoving an implanted lead from a patient, the extractor having aproximal portion, a distal portion, a lumen to receive the lead therein,and a cutter at the distal portion for cutting tissue adjacent theimplanted lead. The extractor and lead are incrementally relativelymovable to swallow the lead as tissue is cut by the cutter adjacent thelead.

In some embodiments, the extractor includes a first clamping member, andthe cutter rotates to cut tissue as the position of the first clampingmember changes. In some embodiments, the first clamping member ismovable between unclamped position and clamped positions, and in theclamped position retraction of the first clamping member causesswallowing of the lead by the extractor. In some embodiments, the firstclamping member is tiltable relative to a longitudinal axis of theextractor to move between the clamped and unclamped positions.

The extractor can include in some embodiments a second clamping membermovable between unclamped position and clamped positions, and in theclamped position retraction of the second clamping member causesswallowing of the lead by the extractor, the first and second clampingmembers alternately moved between clamped and unclamped positions. Theextractor can further include a second clamping member movable betweenunclamped and clamped positions, wherein the first clamping member has afirst hinge and the second clamping member has a second hinge, the firstand second hinges radially spaced from a longitudinal axis of theextractor and lying on opposing sides of the longitudinal axis of theextractor, wherein relative movement of the lead and extractor causespivoting of the first and second clamping members.

The extractor can include a carrier for moving the first clampingmember, the carrier including an engagement tab to engage a slot in ahousing containing the cutter, wherein movement of the carrierconcurrently causes pivoting of the first clamping and rotation of thehousing to rotate the cutter.

In accordance with another aspect, the present invention provides anextractor for removing an implanted lead from a patient, the extractorhaving a lumen to receive the lead and first and second clampingmembers, the clamping members movable between unclamped positions wherethe lead can freely move within the lumen and clamped positions tofrictionally engage the lead, wherein relative movement of the extractorand lead effects pivotable movement of the clamping members.

In some embodiments, further relative movement of the extractor and leadcauses further frictional force by the first clamping member on thelead. In some embodiments, the first clamping member has a first hingeand the second clamping has a second hinge, the first and second hingesradially spaced from a longitudinal axis of the extractor and lying onopposing sides of the longitudinal axis of the extractor.

The extractor can include a movement mechanism for axially moving thefirst clamping member, wherein such axial movement rotates a cutter ofthe extractor.

The first and second clamping members can in some embodiments be springbiased to the clamped positions.

In some embodiments, relative movement of the extractor and lead occursin discrete increments which progressively swallow the lead within thelumen of the extractor.

In accordance with another aspect of the present invention, a method ofremoving an implanted lead from a patient is provided comprising:

-   -   a) providing an extractor having a lumen to receive the lead and        a cutter at a distal portion;    -   b) positioning the extractor so the lead extends through the        lumen of the extractor and the cutter is adjacent or in contact        with the tissue adjacent the lead;    -   c) moving a first clamping member of the extractor in a first        direction to relatively move the extractor and lead to swallow        the lead; and    -   d) cutting tissue adjacent the lead by the cutter.

In some embodiments, the step of cutting tissue includes rotating thecutter. In some embodiments, rotation of the cutter occurs concurrentlywith movement of the first clamping member.

The method can further include the steps of moving a second clampingmember to clamp the lead, and the unclamping the first clamping memberbefore the step of moving the second clamp member proximally andunclamping the second clamping member before the step of moving thefirst clamping member to thereby provide incremental relative movementof the lead and extractor. The method can further comprise the step ofmoving a second clamping member proximally to swallow the lead.

In some embodiments, the first clamping member is released after thesecond clamping member is moved to clamp the lead, and the secondclamping member is released after the first clamping member is moved toclamp the lead.

In some embodiments, the step of moving the first clamping memberincludes the step of tilting the first clamping member with respect to alongitudinal axis of the extractor so it moves from a first angle to asecond different angle.

In some embodiments, the extractor has a second clamping member, and thefirst and second clamping members each have an opening to receive thelead therethrough and changing angles of the first and second clampingmembers with respect to a longitudinal axis of the extractor changes theangle of the first and second openings to clamp the lead.

The method may further include the step of rotating a flexible sheath torotate the lead to unscrew a distal end of the lead from tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 illustrates a patient's anatomy showing an implanted cardiac leadto be removed;

FIG. 2 is a perspective view of one embodiment of the lead extractor ofthe present disclosure;

FIG. 3 is a perspective view of the lead extractor of FIG. 2 positionedover the cardiac lead;

FIG. 4 is a side view of the lead extractor of FIG. 2 with the outerhousing shown in phantom to illustrate the internal rings and springs,the extractor shown in the neutral position;

FIG. 5 is a side perspective view similar to FIG. 4 with the housingremoved for clarity;

FIG. 6 is a side view of the lead extractor of FIG. 2 showing the distalclamp ring moved to the angled position;

FIG. 7 is a side view similar to FIG. 6 showing the proximal clamp ringmoved to the angled position;

FIG. 8 is a close up view a portion of the cutter (knife) of the housingfor cutting tissue;

FIG. 9 is a close up view of the distal end of the housing of FIG. 2;

FIG. 10 is a front view illustrating the cable extending through thenotch in the proximal clamp ring;

FIGS. 11A-11C are schematic views of an embodiment utilizing a motor tomove (oscillate) the cables of the lead extractor to alternatively angleand retract the distal and proximal clamping rings;

FIGS. 12A-12F illustrate side views (with the housing shown in phantom)to show the method of use of the lead extractor of FIG. 2 wherein:

FIG. 12A illustrates the lead extractor in the neutral position with theproximal and distal clamp rings in the substantially perpendicularposition;

FIG. 12B illustrates a first cable pulled proximally to move the distalclamp ring to the angled position;

FIG. 12C illustrates the first cable pulled further proximally to movethe lead proximally;

FIG. 12D illustrates a second cable pulled proximally to move theproximal clamp ring to the angled position;

FIG. 12E illustrates the first cable released to return the distal clampring to its substantially perpendicular and distal position;

FIG. 12F illustrates the second cable pulled further proximally to movethe lead further proximally;

FIGS. 13A-13D are side views of the lead extractor of FIG. 2, with theinternal rings and spring shown in phantom, illustrating how the leadand extractor are relatively moved to cut tissue about the lead wherein:

FIG. 13A illustrates the lead extractor being inserted over an implantedlead to approach the tissue surrounding the lead, the lead extractorshown in the neutral position with the proximal and distal clamp ringsin the substantially perpendicular position;

FIG. 13B illustrates the first cable pulled proximally to move the leadproximally and sever the surrounding tissue;

FIG. 13C illustrates a second cable pulled proximally to move theproximal clamp ring to the angled position;

FIG. 13D illustrates the first cable released to return the distal clampring to its substantially perpendicular position and the second cablepulled further proximally to move the lead further proximally with thesurrounding tissue being severed;

FIG. 14 is a perspective view of an alternative embodiment utilizing amanual control to actuate the cables of the extractor of FIG. 2;

FIG. 15 is a perspective view of an alternate embodiment of the leadextractor of the present disclosure having a flexible tube;

FIG. 16 is a close up perspective view of the area of detail of FIG. 15;

FIG. 17 illustrates a perspective view of another alternate embodimentof the lead extractor,

FIGS. 18A-18D are side views of the lead extractor of FIG. 17, with thesheath shown in cross-section, illustrating how the lead and extractorare relatively moved to cut tissue about the lead wherein:

FIG. 18A illustrates the lead extractor being inserted over an implantedlead to approach the tissue surrounding the lead, the lead extractorshown in the neutral position with the proximal and distal clamp ringsin the substantially perpendicular position;

FIG. 18B illustrates the first cable pulled proximally to move the leadproximally and sever the surrounding tissue;

FIG. 18C illustrates a second cable pulled proximally to move theproximal clamp ring to the angled position; and

FIG. 18D illustrates the first cable released to return the distal clampring to its substantially perpendicular position and the second cablepulled further proximally to move the lead further proximally with thesurrounding tissue being severed.

FIG. 19 is a perspective view of an alternate embodiment of the leadextractor of the present disclosure shown positioned over a cardiaclead;

FIG. 20 is a perspective view of the outer housing of the lead extractorof FIG. 19;

FIG. 21 is a perspective view of the inner housing of the lead extractorof FIG. 19;

FIG. 22 is an exploded perspective view of the lead extractor of FIG.19;

FIG. 23 is a perspective view of the outer housing of the lead extractorof FIG. 19;

FIG. 24 is a cross-sectional view of the outer housing of FIG. 23;

FIG. 25 is a cross-sectional view illustrating the lead extractor in theinitial position and showing the lead extending through the extractor;

FIG. 26 is a cross-sectional view similar to FIG. 25 illustrating thecarrier of the lead extractor moved to the proximal position;

FIG. 27 is a cross-sectional view similar to FIG. 26 illustrating thecarrier of the lead extractor starting to be returned to the initialdistal position;

FIG. 28 is a cross-sectional view similar to FIG. 27 illustrating thecarrier of the lead extractor moved to the distal position;

FIG. 29 is a cross-sectional view similar to FIG. 28 illustrating thecarrier and components of the lead extractor in the initial position;

FIG. 30 is a perspective view corresponding to the position of FIG. 25,the inner and outer housings removed for clarity, and showing the leadextending through the extractor;

FIG. 31 is a perspective view corresponding to the position of FIG. 26,the inner and outer housings removed for clarity;

FIG. 32 is a perspective view corresponding to the position of FIG. 27,the inner and outer housings removed for clarity;

FIG. 33 is a perspective view corresponding to the position of FIG. 28,the inner and outer housings removed for clarity;

FIG. 34 is a perspective view corresponding to the position of FIG. 29,the inner and outer housings removed for clarity;

FIG. 35 is a front view of the lead extractor of FIG. 19;

FIG. 36 is a front view similar to FIG. 35 showing rotation of the outerhousing with respect to the inner housing for cutting tissue;

FIG. 37 is a side view of an alternate embodiment of the lead extractorof the present disclosure having a flexible sheath thereover, the sheathshown in cross-section;

FIG. 38 is a side view similar to FIG. 37 showing rotation of theflexible sheath to rotate the extractor and lead;

FIG. 39 is a side view similar to FIG. 38 showing freeing of the distaltip of the lead from the tissue as a result of rotation of the sheath;

FIG. 40 is a side view similar to FIG. 39 showing removal of theflexible sheath, lead extractor and lead from the body;

FIG. 41 is a perspective view of the actuator in a first (neutral)position;

FIG. 42 is a perspective view of the actuator in a second position topull the cable proximally to retract the carrier of the lead extractor;

FIG. 43 is a perspective view of the actuator in an override position toadvance the carrier of the electrode lead to the distal clamp releaseposition; and

FIG. 44 is a cross-sectional view illustrating the lead extractor in theoverride position to release the clamping rings.

DETAILED DESCRIPTION OF EMBODIMENTS

The lead extractor disclosed herein advantageously holds the leadadjacent the area where the tissue cutting (severing and/or dissecting)occurs, thereby transferring the power of the work required to thelocation where it is needed. This provides an advantage over prior leadextractors where the extractor is held and maneuvered from a proximalend to apply a cutting or dissecting force to the tissue at the remotedistal end. Thus, the lead extractor of the present invention providesfor lead removal with minimal damage to the patient's tissue.

To this end, the present disclosure provides a lead extracting devicewhich grips and frictionally retains the lead, and then incrementallymoves relative to the lead, cutting the surrounding tissue as it ismoved proximally within the device. Note the lead and extractor moverelative to each other. That is, if the distal end of the lead is fixed,the relative movement will occur by the extractor being advanced alongthe lead. If the distal end of the lead is not fixed, relative movementwill occur by the lead moving proximally within the extractor. Also,relative movement can include proximal movement of the lead simultaneouswith distal movement of the extractor. In any case, as a result of thisrelative movement, the extractor “swallows” the lead within its lumen asit incrementally and progressively cuts through tissue around the leadto free the lead from the tissue. Cutting of tissue can occur bysevering and/or dissecting tissue. The cutter is shown as part of thehousing in the embodiments herein, however, alternatively the cutter canbe a separate component attached to the housing.

With reference to FIGS. 2, 4 and 5, the lead extracting device isdesignated generally by reference numeral 10 and includes an outerhousing or body 14 and an internal tubular member or inner body 12having a lumen dimensioned to receive a lead therein. The outer housing(outer tube) 14 has a proximal end 20 and a distal end 30. As usedherein the term “proximal” refers to the portion that is closer to theuser and the term “distal” refers to the portion that is further fromthe user. A cutting knife (cutter) or cutting portion 50 is positionedat the distal end 30 of outer housing 14 configured to cut tissuesurrounding the lead, designated by reference letter “A”. FIG. 1illustrates an anatomical view of the heart, illustrating the locationof the cardiac lead A which is desired to be removed from the rightventricle B. It should be appreciated that the devices disclosed hereinare described for removing a cardiac lead, however, it should beunderstood that the device also has other surgical applications. Notetissue ingrowth around the lead also occurs at regions along the lengthof the lead proximal of the distal tip of the lead.

The lead extractor includes a distal clamping ring 22, a proximalclamping ring 24, a distal fixed ring 26 and a proximal fixed ring 28. Afirst actuator or actuating (movement) mechanism in the form of a firstwire or cable 32 is operably connected to the distal clamping ring 22and a second actuator or actuating mechanism in the form of a secondwire or cable 34 is operably connected to the proximal clamp ring 24.The cable 32 is operable to pivot distal clamping ring 22 from asubstantially perpendicular position to an angled position with respectto the longitudinal axis of the extractor 10. In the substantiallyperpendicular position, the extracting device 10 is freely movable overthe lead A. In the angled (tilted) or oblique position, due to thedimension of the opening in the distal clamping ring 22, the distalclamping ring 22 frictionally engages, i.e., clamps, the externalsurface of the lead A as the surface around the opening in the clampingring 22 frictionally engages the outer surface of the lead. Suchclamping allows relative movement of the lead, i.e., “swallowing” of thelead described in detail below. Similarly, the cable 34 is operable topivot proximal clamp ring 24 from a substantially perpendicular positionto an angled position with respect to the extractor 10. In thesubstantially perpendicular position, the extracting device 10 is freelymovable over the lead A. In the angled (tilted) or oblique position, dueto the dimension of the opening in the proximal clamping ring 24, theproximal clamping ring 24 frictionally engages, i.e., clamps, theexternal surface of the lead A as the surface around the opening in theclamping ring 24 frictionally engages the outer surface of the lead.Such clamping allows relative movement of the lead, i.e., “swallowing”of the lead as described in detail below. A distal spring 36 ispositioned around tubular member 12 to bias the distal clamp ring 22 ina distal direction and a proximal spring 38 is positioned around tubularmember 12 to bias the proximal clamp ring 24 in the distal direction.

First cable 32, also referred to herein as the distal ring cable, isfixedly attached to distal ring 22 (at connection 33), extends throughan aperture 42 in the distal fixed ring 26 and an aperture 44 inproximal fixed ring 28. Proximal clamp ring 24 has a cutout or notch 27to accommodate the first cable 32 (see also FIG. 10). The cable 32extends proximally to a position outside the patient for manipulationmanually by a user or alternatively for connection to a motor asdescribed below.

Cable 34, also referred to herein as the proximal ring cable, is fixedlyattached to proximal ring 24 (at connection 35) and extends through anaperture 46 in the proximal fixed ring 26. The cable 34 extendsproximally to a position outside the patient for manipulation manuallyby a user or alternatively for connection to a motor. The cables 32 and34 thereby provide a movement mechanism for the clamping members.

The extractor 10 preferably has three operable positions. In a first orinitial position, referred to as the neutral or zero position, both thedistal and proximal clamping rings 22, 24 are in the substantiallyperpendicular position in which they do not frictionally retain thecardiac lead and therefore the device 10 can be slidably moved over thelead A, as the lead A extends through the lumen of the tubular member12. In this neutral position, this sliding movement is obtained sincethe inside diameter of the opening in the distal ring and the insidediameter of the opening in the proximal ring 22 is greater, e.g.,slightly greater, than the outside diameter D of the lead A. Note thisneutral position also enables the device 10 at any time during theprocedure to release the lead and be adjusted or removed from the leadand patient. In the second position, the distal ring 22 is moved to theangled position to engage (clamp) the lead A while the proximal ring 24remains in the substantially perpendicular position, as shown in FIG. 6.In the third position, the proximal ring 24 is moved to the angledposition to engage (clamp) the lead A while the distal ring 22 remainsin the substantially perpendicular position, as shown in FIG. 7. Itshould be appreciated that alternatively, the second position can denotewhen the proximal ring 22 is moved to the angled position to engage thelead A and the distal ring 24 remains in the substantially perpendicularposition, in which case the third position would denote the positionwherein the distal ring 22 is moved to the angled position to engage thelead A while the proximal ring 24 remains in the substantiallyperpendicular position.

The knife (cutter) 50 preferably has an angled cutting edge that avoidsthe knife cutting into the vessel wall. The cutting edge is beveled atend 52, and has a small cutting edge 54 (FIG. 8), extending at anopposite angle to the bevel, thereby preventing the knife 50 from goinginto the lead. The knife 50 has a circular design with a sinuous shape,thereby providing a curved knife to perform a relative movement from thecutting edge to the tissue as in a guillotine-like action. The anglesshown in FIG. 8 are by way of example as other angles are alsocontemplated. The inner diameter E of the knife 50 (FIG. 9) preferablyis slightly greater than the outer diameter of the lead A to be receivedin the lumen of device 10.

Turning now to the method of use, and with reference to FIGS. 12A-12F,the device 10 is inserted over the lead A and advanced over the lead Auntil the knife 50 at the distal end 30 of the tubular member 12 is atthe desired site, namely the site where the lead A is embedded orsurrounded by tissue so it cannot be removed. This is typically proximalof the distal tip of the lead. In this position, the device 10 is readyfor lead extraction.

The user than pulls cable 32 proximally, or if motor operated, turns onthe motor which automatically pulls the cable 32 proximally. In thefirst proximal movement of the cable 32, the distal clamping ring 22 ispivoted to its angled position of FIG. 12B to frictionally clamp orgrasp the lead A. Upon further movement of the cable 32, the lead A ispulled back due to its frictional engagement with the device 10 viadistal clamp ring 22 as shown in FIG. 12C and/or the device 10 is movedover the lead in this relative movement to “swallow” the lead A. (Sincethe proximal ring 24 is in its substantially perpendicular ornon-engaging position, the lead can move through the opening in the ring24). As the lead A is moved back proximally in the direction of thearrow of FIG. 12C it begins to be freed from tissue as the surroundingtissue is engaged and cut (severed and/or dissected) by knife 50. As canbe appreciated, the cutting of tissue occurs adjacent the end of thedevice where the lead is engaged, thus providing more leverage andeasier severing of the tissue. As the distal ring 22 is pulledproximally (rearwardly), it compresses distal spring 36. In an exemplaryembodiment, distal clamping ring 22 is pulled back a maximum ofapproximately halfway to the distal fixed ring 26. In an exemplaryembodiment, the distance between distal clamping ring 22 and distalfixed ring 26 is about 20 mm and the distal clamping ring 22 is pulledproximally about 10 mm thereby moving the lead A proximally about 10 mmin the direction of the arrow of FIG. 12C. Other distances are alsocontemplated.

Once the distal clamping ring 22 has been pulled back to relatively movethe lead A proximally or “swallow” the lead a predetermined amount, thesecond cable 34 can now be actuated. The user pulls cable 34 proximally,or if motor operated, the motor automatically pulls the cable 34proximally after the first cable 32 has been pulled. In the firstproximal movement of the cable 34, the proximal clamping ring 24 ispivoted to its angled position of FIG. 12D to frictionally clamp orgrasp the lead A. Once the cable 34 has moved the proximal ring 32 toits angled position, the tension on the first cable 34 is released sothe distal ring 22 can return to its substantially perpendicular ornon-engaged position, aided by the force of distal spring 36 (FIG. 12E).In a preferred embodiment, the first cable 32 (and thus the distal clampring 22) is not released until the second cable 34 has been tensioned tomove the proximal ring 24 to engage the lead A. This helps preventslippage, e.g., distal movement of the lead A, since the lead A iscontinuously being grasped, albeit by alternating the grasping functionbetween the proximal and distal clamping rings 22, 24.

After the cable 34 has been pulled to pivot the proximal clamping ring24 to its angled position, further retraction of the cable 34 pulls thelead A back (proximally) or moves the device 10 distally due to itsfrictional engagement with the device 10 via distal clamp ring 24. Thus,the lead A is relatively moved further back proximally in the directionof the arrow to further free it from surrounding tissue as the tissue iscut by knife 50 as shown in FIG. 12F. As the proximal ring 22 is pulledproximally (rearwardly), it compresses proximal spring 38. In anexemplary embodiment, proximal ring 22 is pulled back a maximum ofapproximately halfway to the proximal fixed ring 28. In an exemplaryembodiment, the distance between proximal clamp ring 24 and proximalfixed ring 28 is about 20 mm and the proximal clamp ring 24 is pulledproximally about 10 mm, thereby relatively moving the lead A about 10mm. Other distances are also contemplated.

Next, the first cable 32 is pulled to once again pivot the distal ring22 to the angled engaging position. Once pulled, the second cable 34 cannow be released, followed by further retraction of the first cable 32,to move the lead proximally due to its frictional engagement. After suchmovement, the second cable 34 is pulled proximally, followed by releaseof the first cable 34, and then further pulling of the cable 34 to movethe lead A still further proximally and to continuously sever thesurrounding tissue by knife 50. This step of alternatively pulling ofthe cables 32, 34 is repeated until the lead A is freed from the tissueand can be removed (with or separately from the device 10) from thetissue. This alternating cable motion can also be referred to as anoscillating movement in that the pulling of the cable alternates betweenthe first and second cables, to incrementally pull the lead proximallyor advance the extractor distally. This alternating action can also beconsidered as a step by step progressive “swallowing” of the lead. Itcan also be considered a tunneling action as it tunnels through tissueto separate tissue from the lead.

FIGS. 13A-13D illustrate how the lead is pulled back relative to tissueT. FIG. 13A shows the lead extractor being inserted over lead A to theposition where the lead is captured by tissue T. After positioning ofthe extractor 10 in the desired position, the first cable 32 is pulledrearwardly and the lead A is retracted or the device 10 advanced asdescribed above, with the tissue T engaging the cutting edge of knife 50to cut the tissue surrounding the lead A to thereby free the lead (seeFIG. 13B). In FIG. 13C, the proximal clamp ring 24 is angled by thepulling of the second cable 34. The first cable 32 is then released, andthe proximal cable 34 is pulled back further to further move the leadproximally or advance the device 10, thereby causing the tissue to againbe into contact with the knife 50 to cut the tissue. As explainedherein, this keeps being repeated so that the knife 50 can continue tocut the tissue as the lead A is incrementally and progressively pulledrearwardly or swallowed within the lumen of tube 12 of the leadextractor 10.

In one embodiment, this alternating movement can be achieved by handlemechanism 80 shown in FIG. 14. The handle mechanism 80 includes a firstactuator 82, illustratively in the form of a pivotable handle with afinger loop 83, and a second actuator 84, also illustratively in theform of a pivotable handle with a finger loop 85. The first actuator 82is operatively connected to the first cable 32 such that proximalmovement of the actuator 82, e.g., moving of the finger loop 83 towardstationary handle 86, pulls the cable 32 proximally and distal movementreturns the cable 32 to its original position. Similarly, secondactuator 84 is operatively connected to the second cable 34 such thatproximal movement of the actuator 84 (away from the stationary handle86) pulls the cable 34 proximally and distal movement returns the cable34 to its original position. The handle mechanism 80 in a preferredembodiment includes a locking mechanism (not shown) to ensure thateither cable 32, 34 cannot be released until the other cable has beenmoved proximally to move its respective clamping ring to the angledclamping position to frictionally engage the lead. A rotation knob 88can be provided to rotate the lead extractor to thereby rotate theclamped lead if desired.

As can be appreciated, the pistol grip and pivotable handles are shownby way of example as other handle configurations and other types ofactuators, e.g., sliding tabs, are also contemplated to provide manualcontrol of the cable movement.

In an alternate embodiment, an external power source such as a motorassembly is provided to electrically drive (actuate) the cables insteadof the manual operation by the user. As shown schematically in FIG. 11A,motor rotation of the wheel 90, which is preferably eccentric, from theneutral position of FIG. 11A to the position of FIG. 11B, pulls cable 32proximally to move the distal clamping ring 22 to the angled positionand then to pull the distal clamping ring 22 proximally to retract orswallow the clamped lead as described above. Rotation of the wheel inthe opposite direction (FIG. 11C) will cause cable 34 to be pulledproximally to move the proximal clamping ring 24 to the angled positionand to pull the proximal clamping ring 24 proximally to retract theclamped lead further proximally or further swallow lead. Thus, as can beappreciated, the motor causes the oscillating motion of the wheel andrespective cables to incrementally relatively retract the lead. Itshould be appreciated that the motor controlled embodiment can beconfigured so that the clamping ring cannot be released from its angledposition until the other clamping ring is moved to its angled clampingposition as described above. Note that such motor operated cables can beutilized with the other embodiments disclosed herein, e.g., extractor200 discussed below.

FIGS. 15-18 illustrate an alternate embodiment of the lead extractor,designated generally by reference numeral 100. The lead extractor 100 isidentical to the lead extractor 10 of FIG. 2 except for provision of theflexible tube/sheath. Therefore, the identical components have beenlabeled with corresponding numbers in the “100 series” so that extractor100 has a knife (cutter) 150, distal clamping ring 122, a proximalclamping ring 124, a distal fixed ring 126, a proximal fixed ring 128, afirst cable 132 operably connected to the distal clamp ring 122 and asecond cable 134 operably connected to the proximal clamp ring 124. Thecable 132 is operable to pivot distal clamping ring 122 from asubstantially perpendicular position to an angled position and the cable134 is operable to pivot proximal clamping ring 124 from a substantiallyperpendicular position to an angled position. As in the embodiment ofFIG. 2, a distal spring 136 is positioned around tubular member 112 tobias the distal clamping ring 122 in a distal direction and a proximalspring 138 is positioned around tubular member 112 to bias the proximalclamping ring 34 in the distal direction.

The extractor 100 differs from extractor 10 in that a flexible tube(sheath) 160 having a handle 162 is provided. The handle 162 enables theextractor 100 to be rotated to thereby rotate the clamped lead. Suchrotation provides an unscrewing action of the lead if the user deems itdesirable. Thus, after the extractor 100 cuts the tissue surrounding thelead, the user can keep the extractor 100 locked to hold the lead, andthe sheath can be rotated to facilitate removal of the embeddedscrewed-in tip of the lead. Note the tube 160 has a plurality of cutoutsin the wall to provide the desired flexibility. The housing 114 can alsohave a plurality of cutouts in the wall to provide the desiredflexibility. In the alternate embodiment of FIG. 17, a sheath 170 isprovided to cover the flexible tube 160.

FIGS. 18A-18D illustrate the use of extractor 100 which is identical tothe use described in conjunction with FIGS. 13A-13D except for provisionof a flexible sheath 170 in which the housing 114 is positioned. Thus,as can be appreciated the movement of the clamping rings 122 and 124,and relative movement of the extractor 10 and the lead A shown in FIGS.18A-18D are identical to that of FIGS. 13A-13D and for brevity are notrepeated herein.

Although two clamping rings are described in the embodiments herein, itis also contemplated that a single clamping ring or more than oneclamping ring can be utilized.

An alternate embodiment of the lead extractor of the present inventionis illustrated in FIGS. 19-36. The lead extractor is designatedgenerally by reference numeral 200 and includes an outer body (outerhousing) 202 and an inner body (inner housing) 204. The lead extractor200 is similar to lead extractor 10 described above in that it isconfigured to move relative to the lead to “swallow” the lead inincrements. However, in the lead extractor 10 of FIG. 2, the usermanipulates the actuators to selectively control pivoting of theclamping members, alternately clamping and releasing the distal andproximal clamping members. In the lead extractor 200 of FIG. 19, thechanged orientation of the clamping members is a result of the relativemovement of the lead extractor 200 and lead. Additionally, the leadextractor 200 has an enhanced cutting action as the cutter also rotates.Other differences between extractor 200 and extractor 10 will becomeapparent from the detailed description below of extractor 200.

Turning to the components of lead extractor 200, and with reference toFIGS. 20-24, outer body (or outer tube) 202 of lead extractor 200 has aproximal portion 206, a distal portion 208 and an intermediate portion207 therebetween. A cutter or cutting portion 210 is formed at thedistal portion 208 and preferably includes a serrated edge or toothededge to effectively cut tissue adjacent the lead. Outer body 202 ispositioned coaxially over inner housing (or inner tube) 204 as the innerhousing 204 is received in lumen 216 of outer body 202. Outer body 202has an internal helical slot 218 and is rotatable relative to innerhousing 204 (see FIGS. 35 and 36) to cut (sever and/or dissect) tissueas described in more detail below. Outer housing 202 has a conical tip202 a tapering in a distal direction to facilitate tunneling of thedevice. Radial slots 212, 214 receive disc 231 and another disc (notshown) or bars which are welded to the outer tube 202 to keep the device200 together. Also, these block axial movement of the outer body 202 sothat when the carrier 240 moves axially, since axial movement of theouter body 202 is blocked, it is forced to rotate.

With reference to FIGS. 21-22, the inner housing 204 has a proximalportion 220, a distal portion 222 and an intermediate portion 226between the proximal portion 220 and distal portion 222. A cutter orcutting portion 224, preferably having a serrated or toothed edge asshown, interacts with the cutting portion 210 of outer housing 202 tosever tissue adjacent the lead. That is, the cutting portion 210 ofouter housing 202 overlies a counterpart cutting portion 224 of innerhousing 204. A circumferential slot 230 is formed between ring 234 anddistal end 232 of the carrier receiving portion to receive semicirculardisc 231.

Inner housing 204 has a pair of proximally extending arms 238 to form agap to slidably receive carrier or vehicle 240. Movement of carrier 240effects relative movement of the extractor 200 and lead. A proximal endcap 249 is secured within top and bottom notches 238 a of arms 238 tosecure the arms 238 and provide a back wall enclosure for the innerhousing 204. Carrier 240 is slidably mounted within inner housing 204for movement between proximal (retracted) and distal positions, proximaldefined as noted above as the region closer to the user and distal asthe region further from the user (and closer to the tip of the lead).The movement of carrier 240 provides the desired clamping of the leadwhich is positioned within the lumen 228 of inner housing 204. A cable330 described in detail below effects movement of the carrier 240.

Carrier 240 is formed by proximal fixed support ring 242, distal fixedsupport ring 250, upper support 274 and lower support 280. The terms“upper” and “lower” as used herein refer to the orientation of thedevice in the orientation shown in the drawings and are used herein forease of description. Clearly, if the orientation of the device changes,the references “upper” and “lower” will also accordingly change.Contained within carrier 240 is proximal clamping ring 260 which has ahinge point on its lower surface and is biased by proximal spring 266 toa tilted position (with respect to the longitudinal axis of theextractor 200 and lead) as shown in FIGS. 21 and 25. In this tiltedposition (tilted toward the distal end of the device), the proximalclamping ring 260 provides a clamping force on the lead as its centralopening 264 is sufficiently angled with respect to the outer surface ofthe lead so the surface surrounding opening 264 grasps (clamps) thelead. Upper support 274 has a distal notch 278 a seated within uppernotch 252 of distal fixed support ring 250 and a proximal notch 278 bseated within upper notch 244 of proximal fixed support ring 242 toretain and secure these components. Similarly, lower support 280 has adistal notch 284 a seated within lower notch 254 of distal fixed supportring 250 and a proximal notch 284 b seated within lower notch 246 ofproximal fixed support ring 242 to retain and secure these components.Upper tabs 276 a, 276 b of upper support 274 and lower tabs 282 a, 282 bof lower support 280 interact with the helical slot 218 formed in theouter housing 202 described in more detail below. Proximal clamping ring260 receives elongated portion 274 a of upper support 274 in upper slot262. A similar slot on the opposing (bottom) side of proximal clampingring 260 receives lower support 280. A slot 268 of proximal spring 266accommodates upper support 274. Spring 266 is hinged at a bottom portionand has an opening 270 through which the lead can extend. Spring 266 ispreferably attached to proximal clamping ring 260.

Distal of carrier 240, positioned within inner housing 202 between arms238, is a distal clamping ring 290 which has a hinge point on the topsurface and is biased by distal spring 302 to the tilted position asshown in FIGS. 21 and 25. Spring 302 is preferably attached to distalclamping ring 290 and hinged at a top portion. As can be appreciated,the distal clamping ring 290 and proximal clamping ring 260 have hingepoints on opposing sides of the longitudinal axis of the device 10. Inthe tilted position of FIG. 21, (tilted toward the proximal end of thedevice), the distal clamping ring opening 290 is at a sufficient anglewith respect to the lead such that the lead is clamped by the ring 290.A ridged, toothed or irregular surface 295 is formed around part oralternatively the entire circumference of opening 292 in distal clampingring 290 to enhance clamping of the lead extending therethrough when thedistal clamping ring 290 is in the tilted position. Such ridged, toothedor irregular surface can also be provided around part or the entirecircumference of the opening 264 of proximal clamping ring 260 toenhance clamping of the lead.

Clamp engaging member 308 has a distal tab 314 and proximal tab 312.Clamp engaging member 310 similarly has a distal tab 320 and a proximaltab 318. The clamp engaging members 308, 310 are seated within sidenotches 294, 296, respectively, of distal clamping ring 290. The tabs314, 312, 318, and 320 support and retain the upper end of the distalclamping ring 290.

Cable 330 (FIG. 25) includes an outer cable 331 which is attached to theend cap 249 of inner housing 204. Coaxially positioned within the outercable 331 is inner cable 333 which extends distally from outer cable 331and is attached to the fixed proximal ring 242 of carrier 240. Cable 333provides a movement mechanism as proximal movement of inner cable 333pulls the carrier 240 in a proximal direction and distal movement of theinner cable 333 pushes the carrier 240 in a distal direction. The cable333 is actuated by a trigger 340 shown in FIG. 41 and described inconjunction with the method of use.

The use of the extractor 200 will now be described for use to extract animplanted cardiac lead, it being understood it can be used to extractother leads or other components/devices. Oftentimes, tissue ingrowth andplaque builds around the lead over a period of time which makesextraction difficult. The extractor 200 functions to extract the lead byapplication of the force at the distal end. That is, the lead extractor200 is advanced in steps (increments) relative to the lead, therebycutting e.g., severing and/or dissecting, tissue about the lead andtunneling around the lead to cut it away from tissue. When the tissuehas been cut away, the lead can be extracted from the heart tissue. Theextractor 200 and lead A are relatively movable with respect to eachother. Therefore, if the lead is fixed, then the extractor 200 will moveprogressively (in discrete increments) over the lead; if the lead is notfixed, then the extractor will progressively pull the lead (in discreteincrements) back into the extractor 200. Alternatively, both theextractor and lead can move in opposing directions. In any event, thisrelative movement causes the “swallowing” of the lead by the extractor200.

FIGS. 25-29 show in cross-sectional views operation of the extractor200. FIGS. 30-34 are perspective views corresponding to the respectivepositions of FIGS. 24-29, however the inner housing 204 and outerhousing 202 have been removed for clarity.

In use, the device 200 is inserted over a proximal end of the lead,e.g., a cardiac lead, which is embedded in tissue and desired to beremoved. The extractor 200 is advanced until the distal end 208 of theouter housing 202 encounters hard tissue. Note, in the insertionposition, the proximal clamping ring 260 is tilted toward the distal endand the distal clamping ring 290 is tilted toward the proximal end asshown in FIGS. 25 and 30. In this position, the extractor 200 can beforced over the lead A with the openings 292 and 264 of distal andproximal clamping rings 290, 260 providing a sufficient gap (upon suchforce being applied) for passage of the outer diameter of the lead andnot providing a sufficient clamping or frictional force on the lead A toprevent such passage. In this initial position for insertion over thelead, springs 266 and 302 are not compressed and bias the clamping rings260, 290, respectively in the tilted positions shown. Note the clampingrings 260, 290 can optionally be moved to a less tilted position bymovement to the override position described below for initial insertionof the lead, however, in this embodiment it is not necessary since theextractor 200 can be forced over the lead.

When hard tissue, e.g., plaque, is encountered so that the extractor 200cannot be further advanced sufficiently easy over the lead, the useractuates trigger 340 (FIG. 42) to thereby pull inner cable 333proximally, which pulls the carrier 240 proximally since cable 331 isattached to the fixed proximal ring 242. When the carrier 240 is pulledback, shown by the proximally pointing arrows of FIG. 26, the extractor200 is advanced distally over the lead A as proximal clamping ring 260clamps lead A. Note the more relative movement of carrier 240 and leadA, the more tilting of the proximal clamping ring 260 and more clampingforce applied to the lead A. Simultaneous with such proximal movement ofthe carrier, the outer housing 202 rotates, preferably about 45 degreesalthough other degrees of rotation are also contemplated, due to theengagement of tabs 276 a, 276 b (of upper support 274) and theengagement of tabs 282 a, 282 b (of lower support 280) with the internalhelical slot 218 of outer housing 202. This axial and rotationalmovement of outer housing 202, in cooperation with the stationary(non-rotating) cutting portion 224 of inner housing 204, facilitates thecutting portions cutting through tissue around the lead A. Thisretracted position of carrier 240 is also shown in FIG. 31. Note as thecarrier 240 is retracted, distal clamp ring 290 is pivoted about upperhinge point in a clockwise direction, compressing spring 302. Therelative movement of the extractor 200 and lead A causes the distalclamping ring 290 to move to this less angled position of FIG. 26 tofacilitate movement of the extractor 200 as the opening in the distalclamping ring 290 provides a larger diameter with respect to the outerdiameter of the lead A and no longer provides a restrictive clampingforce on the lead A. Although the angle of the proximal clamping member260 might not substantially change during such retraction of carrier240, remaining in substantially the same position as in FIG. 25, biasedby spring 266, it will tilt more if needed such as if a larger force isapplied.

Next, the trigger 252 is returned to the neutral position (FIG. 41),thereby pushing cable 331 distally, which pushes the carrier 240distally in the direction of the arrow of FIG. 27 to reset the extractor200 for the next incremental movement. As shown in FIGS. 27 and 31, inthe initial movement of the carrier 240 distally, the interaction withthe lead A pivots the proximal clamping ring 260 about its bottom hingein a counterclockwise direction to a more vertical position, therebycompressing spring 266, and creating a larger diameter gap about opening264 with respect to the outer diameter of the lead A to facilitatemovement of the extractor 200 with respect to the lead A. The carrier240 thereby moves to the distal position of FIGS. 28 and 33, withproximal clamping ring 260 remaining in the less tilted (and unclamped)position as a result of such movement. Distal clamping member 290returns to the tilted position of FIG. 25 as the extractor 200 is movedrelative to lead A and it remains in the tilted clamping position toclamp the lead A and prevent the lead shifting back, i.e., reversingitself. Such distal movement of carrier 240 causes the outer housing 202to rotate during its axial advancement due to the tab/helical slot 218engagement discussed above, the axial movement and rotation of thecutter (rotating relative to the fixed cutting portion of inner housing204) cutting tissue around the lead A. Note the clamping member 290prevents the lead from moving back and there is no (or little) relativemovement of the lead and extractor 200. However, the outer housing 202will still rotate upon movement of the carrier 240, thus making the samebut opposite cutting movement when the carrier 240 is moved distally.

After full distal travel of the carrier 240 with respect to the lead A,the carrier 240 returns to the position of FIGS. 29 and 34, which is thesame position of FIGS. 25 and 30. Note that the relative movement of theextractor 200 and the lead A causes automatic tilting of the clampingrings 260 and 290. That is, due to the angular positioning of theclamping rings 290, 260, and the top and bottom hinge points, theyoperate as follows: when the carrier 240 is moved proximally to swallowthe lead A, proximal clamping ring 290 remains in the same angularposition (although it is moved axially) and distal clamping ring 290 isrotated by the lead to a less angled position; and when the carrier 240is moved distally to reset, the distal clamping ring 290 returns, due tothe lead (and assisted by spring 302), to the tilted (angular) positionto prevent reverse relative movement with the lead and the proximalclamping ring 260 is tilted by the lead A to a less angled (movevertical) position. Such rotation or tilting of proximal clamping ring260 compresses the biasing spring 266.

Note that the proximal and distal clamping rings 260, 290 do not performa clamping function when they are not sufficiently tilted, i.e., whenthey are in a substantially vertical position. The springs 266, 302 aidthe clamping rings 260, 290 in making the initial tilting to a moreangled position. As soon as the clamping rings 260, 290 start locking onthe lead as a result of relative axial movement, the tilting increasesand the locking force increases. The greater the force, the better thelocking on the lead.

The above steps of FIGS. 25-29 are then repeated the desired number oftimes by actuation of the trigger (actuating member) 340. As can beappreciated, the trigger or actuator 340 is repeatedly pulled andreleased, to cause progressive and incremental relative movement of theextractor 200 and lead A to cut, e.g., sever and/or dissect, tissueadjacent the lead and “swallow” the lead A to free the lead from thesurrounding tissue so it can be removed from the body. As can also beappreciated, this movement and tunneling action of the extractor 200results in the removal force applied at the distal end of the device,adjacent the tissue engagement of the lead.

In certain instances it may be desirable to quickly abort the procedureand quickly remove the extractor 200 from the lead. This requires theclamping rings 260, 290 to be moved to the less tilted unclampingposition. This is shown in FIGS. 43 and 44. FIGS. 41 and 42 show normaluse of the trigger 352. As noted above, when trigger 340 is pulled back,it pulls back on cable 331 to retract the carrier 240; when trigger 340is moved forward (distally), it pushes the carrier 240. This is thenormal use of trigger 252 to achieve desired movement of the carrier andrelative movement (“swallowing”) of the lead. However, if during theprocedure, the user desires to quickly remove the extractor 200, thetrigger 340 is moved to its forwardmost (distalmost) position to movethe carrier 240 to an advanced override position. This override positionis distal of the carrier position of FIGS. 25 and 30. In this position,the carrier 240 is advanced so the distal edge 275 of upper support 274contacts a proximal end 290 a of distal clamping ring 290 forcing it toa less tilted position, and in some embodiments a position close toabout 90 degrees with respect to the longitudinal axis of the lead A.Such movement of the carrier 240 with respect to the lead A also causesthe proximal clamping ring 260 to move to the less tilted position as itdoes in FIGS. 27 and 28. Thus, with the less tilted position and largergaps of the openings 292 and 264 in clamping rings 290, 260 with respectto the outer diameter of the lead, the extractor 200 can more freelyslide over the lead A and be removed from the patient's body. Note adetent can be provided to limit movement of the trigger to the positionof FIG. 41, and then overridden by application of sufficient force tomove the trigger to the override position. Alternatively, a latch orother locking mechanism can be provided to restrict movement of thetrigger to the position of FIG. 41, and released to allow movement oftrigger 340 to the position of FIG. 43 to cancel the procedure. Also, aretention mechanism can be provided to retain the trigger in theoverride position.

Note in some embodiments the trigger 340 can be in the neutral positionof FIG. 41 and then return to the position of FIG. 41 when released fromthe position of FIG. 42. Also, the trigger mechanism can include a stopsuch as a detent, which would prevent movement of the trigger 340 to theoverride position of FIG. 43 during its normal use, and requiresufficient force of the trigger 340 to override the detent to force itinto the override position of FIG. 43.

Note alternatively an external power source such as a motor can beprovided to electrically drive (actuate) the cable 333 instead of manualoperation by the user.

In an alternate embodiment illustrated in FIGS. 37-40, a flexible sheath370 is provided which enables unscrewing of the lead at the distal end.The sheath 370 also has sufficient rigidity to allow for rotation. Thelead extractor 200′ is the same as lead extractor 200 except for theprovision of the sheath positioned over a portion of the extractor 200′.The extractor 200′ is used in the identical fashion as extractor 200described above to separate the lead from the tissue encapsulating thelead along its length. Therefore, for brevity, the components of theextractor 200′ and their function will not be repeated herein as theyare identical to extractor 200, and identical components, e.g., outerhousing 202′, distal clamping ring 290′, and proximal clamping ring 260′are labeled with “prime” designations. The sheath 370 is attached to theproximal end cap 249′ of the inner tube 204′ and extends proximally ofthe end cap 249′, forming an extension of the inner tube 204′. After theextractor 200′ has completed its tunneling action as described above andthe lead A is free from tissue proximal to its embedded distal end, theflexible sheath 370 is rotated (FIG. 38), which in turn rotates theextractor 200′. Since the lead A is firmly clamped by the extractor200′, rotation of the sheath 370 also rotates the lead A, therebyunscrewing the distal tip B of the lead A which is embedded in tissue(FIG. 39). The sheath 370, extractor 200′ and clamped lead A can then beremoved from the body as shown in FIG. 40.

Although described for extracting a lead, the extractors of the presentdisclosure can also be utilized in other surgical applications.

While specific embodiments have been described above, it will beappreciated that the invention may be practiced otherwise than asdescribed. Moreover, specific items discussed with reference to any ofthe isolated drawings may freely be inter-changed supplementing eachouter in any particular way. The descriptions above are intended to beillustrative, not limiting. Thus, it will be apparent to one skilled inthe art that modifications may be made to the invention as described inthe foregoing without departing from the scope of the claims set outbelow.

1. An extractor for removing an implanted lead from a patient, theextractor comprising a proximal portion, a distal portion, a lumendimensioned to receive the lead therein, a cutter at the distal portionfor cutting tissue adjacent the implanted lead, a first clamp configuredto apply a clamping force to the lead and spaced proximally of thecutter, and a second clamp configured to apply a clamping force to thelead and axially spaced from the first clamp, the first clamp movablebetween a clamping position to clamp the lead and an unclamping positionto unclamp the lead, and the second clamp movable between a clampingposition to clamp the lead and an unclamping position to unclamp thelead, the extractor and lead being relatively movable to remove thelead, wherein the first clamp is movable axially toward and away fromthe second clamp to alter an axial distance between the first and secondclamps so the axial distance differs in first and second positions ofthe first clamp.
 2. The extractor of claim 1, further comprising anactuator operatively associated with the first clamp wherein movement ofthe actuator between proximal and distal positions alters an orientationof the first clamp to move it between the clamping and unclampingpositions.
 3. The extractor of claim 1, wherein the first clamp ispositionable in the clamped position while the second clamp ispositionable in the unclamped position.
 4. The extractor of claim 3,wherein the second clamp is pivotable relative to the longitudinal axisof the lead to apply a clamping force on the lead to clamp the lead. 5.The extractor of claim 4, wherein the first and second clamps arealternatively movable between the clamped and unclamped positions sothat the first clamp clamps the lead while the second clamp is in anunclamped position to allow relative movement of the extractor and leadand the second clamp clamps the lead while the first clamp is in anunclamped position to allow relative movement of the extractor and lead.6. The extractor of claim 1, wherein the first clamp has a first hingeand the second clamp has a second hinge and the first and second clampstilt toward each other, the first and second hinges radially spaced froma longitudinal axis of the extractor and lying on opposing sides of thelongitudinal axis of the extractor.
 7. The extractor of claim 1, furthercomprising a cable operatively associated with the first clamp, whereindistal movement of the cable advances the first clamp distally andproximal movement of the cable retracts the first clamp proximally. 8.The extractor of claim 1, further comprising a stop to limit distaltravel of the first clamp, wherein the stop can be overridden to releasethe first and second clamps.
 9. The extractor of claim 1, wherein thecutter is both axially movable and rotatable concurrently in response toaxial movement of the first clamp. 10-11. (canceled)
 12. An extractorfor removing an implanted lead from a patient, the extractor having aproximal portion, a distal portion, a lumen to receive the lead therein,a first clamp configured to apply a clamping force to the lead andmovable between unclamped and clamped positions, and a rotatable tissuecutter at the distal portion configured for cutting tissue adjacent theimplanted lead, the extractor and lead incrementally relatively movableto swallow the lead as tissue is cut by the tissue cutter adjacent thelead, wherein axial movement of the first clamp automatically andconcurrently rotates the tissue cutter about a longitudinal axis. 13-14.(canceled)
 15. The extractor of claim 12, further comprising a secondclamp configured to apply a clamping force to the lead and movablebetween unclamped and clamped positions, wherein relative movement ofthe lead and extractor causes pivoting of the first and second clamps.16-20. (canceled)
 21. An extractor for removing an implanted lead from apatient, the extractor comprising: a lumen dimensioned to receive thelead therein; a tissue cutter at a distal portion, the tissue cutterconfigured for cutting tissue adjacent the lead; a distal clampconfigured to selectively engage and clamp an external surface of thelead when the lead is positioned within the lumen, the distal clampspaced proximally of the cutter; and a proximal clamp configured toselectively engage the external surface of the lead when the lead ispositioned within the lumen, the proximal clamp spaced proximally of thedistal clamp, the proximal clamp movable axially with respect to thedistal clamp for extraction of the lead from the patient, the proximalclamp movable axially between positions closer and further from thedistal clamp.
 22. The extractor of claim 21, further comprising a cableoperatively associated with the proximal clamp, the cable movablebetween first and second positions to move the proximal clamp betweendistal and proximal positions.
 23. The extractor of claim 22, whereinmovement of the proximal clamp proximally effects extraction of the leadas the extractor is advanced distally over the lead and movement of theproximal clamp distally resets the proximal clamp for subsequentproximal movement of the proximal clamp for further extraction of thelead.
 24. The extractor of claim 21, wherein the distal clamp issubstantially stationary as the proximal clamp moves between distal andproximal directions.
 25. The extractor of claim 21, further comprising afirst spring for biasing the distal clamp and a second spring forbiasing the proximal clamp.
 26. The extractor of claim 21, furthercomprising a carrier slidable axially between proximal and distalpositions to carry the proximal clamp between proximal and distalpositions, and the cutter is rotatable in response to axial movement ofthe carrier.
 27. The extractor of claim 12, wherein the first clamp hasa plurality of teeth engageable with the lead.
 28. The extractor ofclaim 12, wherein the tissue cutter is formed on an outer housing of theextractor and the extractor includes an inner housing positioned withinthe outer housing, and the outer housing has an internal helical slotand is rotatable relative to the inner housing.
 29. The extractor ofclaim 28, wherein the inner housing has a cutting portion interactingwith the tissue cutter of the outer housing.